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Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01499056
First Posted: December 26, 2011
Last Update Posted: December 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Royan Institute
  Purpose
Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant problems. First-line of management for patient with osteoarthritis consists of weight reduction, education, and analgesic medication. If necessary, invasive treatment like total hip replacement are performed for the patient. The objective of this study was to assess the safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip osteoarthritis

Condition Intervention Phase
Hip Osteoarthritis Biological: stem cell injection Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation the Side Effect of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Osteoarthritis of Hip Joint

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • swelling of hip joint [ Time Frame: 2 months ]
    Evaluatin the swelling of hip joint by physical examination after intra articular injection.

  • deterioration of joint function [ Time Frame: 2 months ]
    Evaluation deterioration of joint function by physical examination after intra articular cell injection.

  • skin allergic reaction [ Time Frame: 1 week ]
    Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.

  • Respiratory reaction [ Time Frame: 1 week ]
    Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.


Secondary Outcome Measures:
  • Quantitative changes in pain intensity [ Time Frame: 2 months ]
    Evaluation Quantitative changes in pain intensity measured by Visual Analogue Scale after intra articular cell injection 2 months after cell transplantation in compare with base line (before injection)

  • physical function improvement [ Time Frame: 2 months ]
    Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score.

  • subchondral bone edema [ Time Frame: 2 months ]
    Evaluation the subchondral bone edema by MRI

  • cartilage thickness [ Time Frame: 2 months ]
    measuring the cartilage thickness after cell transplantation by MRI


Enrollment: 6
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hip osteoarthritis
The patients with hip joint osteoarthritis who underwent cell injection
Biological: stem cell injection
intra articular inection of mesenchymal stem cell

Detailed Description:
This is a phase one clinical study designed to investigate the safety of intra-articular injection of cultured autologous BM-MSCs in patients with severe hip osteoarthritis candidate for total hip replacement. All subjects will undergo bone marrow aspiration. Autologous MSCs will be extracted and cultured for 4 weeks. Patients will receive intra-articular injection of cultured MSCs under the guide of fluoroscopy. Paraclinical studies (X-Ray and MRI) will be done before and 6 months after treatment. Pain relief and functional improvement of the joint will be assessed by VAS, WOMAC, and Harris Hip Score questionnaire before treatment, and 2 and 6 months after treatment.
  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis diagnosed by MRI
  • End stage osteoarthritis candidate for total hip replacement

Exclusion Criteria:

  • Pregnancy or lactating
  • Positive tests for HIV, HCV, HBV
  • Active neurologic disorder
  • End organ damage
  • Uncontrolled endocrine disorder
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499056


Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Head of Royan Cell therapy Center
Principal Investigator: Mohsen Emadeddin, MD scientist
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01499056     History of Changes
Other Study ID Numbers: Royan-Bone-008
First Submitted: December 17, 2011
First Posted: December 26, 2011
Last Update Posted: December 26, 2011
Last Verified: January 2010

Keywords provided by Royan Institute:
osteoarthritis
hip joint
mesenchymal stem cell

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases